Background <p>In tropical countries like India, amoebic liver abscesses (ALA) account for almost two-thirds of the reported cases of liver abscess. This study aims to compare the efficacy, tolerability, and patient satisfaction scores of three leading nitroimidazole derivatives: metronidazole (MNZ), tinidazole (TIN), and secnidazole (SEC) against amoebic liver abscesses.</p> Material and methods <p>This is a single-center, triple-arm randomized controlled trial study in which patients diagnosed with ALA were randomized into three treatment groups: metronidazole (MEN), tinidazole (TIN), and secnidazole (SEC). The primary outcomes observed in this study were the resolution of symptoms and signs, including fever, abdominal pain, right hypochondrium tenderness, and leukocytosis. Drug-related side effects, patient satisfaction scores, and complications like rupture of abscess, atelectasis, or pleural effusion were secondary outcomes of the study.</p> Results <p>A total of 150 patients were randomized equally into three MEN, TIN, and SEC groups. Drug-related side effects were reported as minimal with TNZ, while MNZ had maximum side effects and tolerability issues (<i>p</i> &lt; 0.0001).</p> Conclusion <p>Compared to MNZ and SEC, TNZ exhibits a rapid clinical response, an early resolution of pain and fever, good tolerance with minimal side effects, and high patient satisfaction scores. Although SEC’s side effects were similar to MNZ, TIN consistently showed superior safety and efficacy compared to both.</p> Trial registration <p>CTRI No CTRI/2022/01/039430</p>

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Triple-arm randomized controlled trial comparing metronidazole, tinidazole, and secnidazole in the treatment of amoebic liver abscess: the TARMENTS trial

  • Jitendra Kumar,
  • Samar Iftikhar,
  • Shardool Vikram Gupta,
  • Rajiv Ranjan Kumar,
  • Renu Gur,
  • Sandeep Kumar

摘要

Background

In tropical countries like India, amoebic liver abscesses (ALA) account for almost two-thirds of the reported cases of liver abscess. This study aims to compare the efficacy, tolerability, and patient satisfaction scores of three leading nitroimidazole derivatives: metronidazole (MNZ), tinidazole (TIN), and secnidazole (SEC) against amoebic liver abscesses.

Material and methods

This is a single-center, triple-arm randomized controlled trial study in which patients diagnosed with ALA were randomized into three treatment groups: metronidazole (MEN), tinidazole (TIN), and secnidazole (SEC). The primary outcomes observed in this study were the resolution of symptoms and signs, including fever, abdominal pain, right hypochondrium tenderness, and leukocytosis. Drug-related side effects, patient satisfaction scores, and complications like rupture of abscess, atelectasis, or pleural effusion were secondary outcomes of the study.

Results

A total of 150 patients were randomized equally into three MEN, TIN, and SEC groups. Drug-related side effects were reported as minimal with TNZ, while MNZ had maximum side effects and tolerability issues (p < 0.0001).

Conclusion

Compared to MNZ and SEC, TNZ exhibits a rapid clinical response, an early resolution of pain and fever, good tolerance with minimal side effects, and high patient satisfaction scores. Although SEC’s side effects were similar to MNZ, TIN consistently showed superior safety and efficacy compared to both.

Trial registration

CTRI No CTRI/2022/01/039430